Associate Director, Regulatory Affairs CMC Hybrid Onsite

The Associate Director Regulatory Affairs Chemistry Manufacturing and Controls (CMC) works with internal and external partners to deliver products to patients. This role offers the opportunity to apply and further develop regulatory and technical expertise in small molecule CMC development of peptides and sterile injectables .

This individual prepares CMC regulatory strategies that enable first pass approvals. Develops and manages content strategy for regulatory submissions including INDs / CTAs and amendments new marketing applications and supplements / variations. Builds and maintains relationships within the Regulatory Affairs functional areas Operations and Research & Development (R&D) organizations. Represents CMC on teams such as product development Global Regulatory Product Teams and Operations brand teams to negotiate influence and provide strategic advice. Serves as strategic liaison with the regulatory agencies (e.g. FDA) regarding CMC matters.

Scope of Responsibility :

• Prepares CMC regulatory product strategies. Prepares and manages regulatory submissions including new applications and amendments renewals annual reports supplements and variations and responds to regulatory information.
• Analyzes and interprets information that impacts regulatory decisions. Seeks expert advice and technical support as required for strategies and submissions
• Reviews and revises regulatory submissions to effectively present data and strategy to regulatory agencies
• Develops strategies for CMC agency meetings manages preparation for agency meetings and manages content of pre-meeting submissions. Serves as the point of contact for the regulatory agency meetings.
• Manages products and change control with an understanding of regulations and company policies and procedures. Analyzes and approves manufacturing change requests.
• Represents CMC regulatory affairs on teams such as the product development Global Regulatory Product Teams and Operations brand teams for assigned projects; negotiates with and influences team members with support of management to maximize chances for first pass approval of regulatory submissions
• Stays abreast of regulatory procedures and changes in regulatory climate. Analyzes legislation regulation and guidance provides analysis to the organization
• Develops implements and documents policies and procedures within the regulatory affairs department. Leads initiatives internal to RA CMC.
• Represents CMC regulatory affairs on project initiatives with other functional areas to drive efficiencies across the company.
• Trains develops and mentors individuals; may include formal supervisory responsibilities

This role is an onsite hybrid opportunity based in AbbVies Lake County IL office.

Qualifications :

Additional Information :

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law :

The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location and we may ultimately pay more or less than the posted range. This range may be modified in the future.

We offer a comprehensive package of benefits including paid time off (vacation holidays sick) medical / dental / vision insurance and 401(k) to eligible employees.

This job is eligible to participate in our short-erm incentive programs.

This job is eligible to participate in our long-term incentive programs

Note : No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of any bonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer / Veterans / Disabled.

US & Puerto Rico only - to learn more visit  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more :

Work :

No

Employment Type : Full-time

Key Skills

Proofreading,Adobe Acrobat,FDA Regulations,Manufacturing & Controls,Biotechnology,Clinical Trials,Research & Development,GLP,cGMP,Product Development,Chemistry,Writing Skills

Experience : years

Vacancy : 1